CETERA assures that all regulatory commitments are in place. In Portugal, we support the full submission and report to the three Portuguese entities responsible for the regulatory assessment of a clinical study either testing an investigational medicinal product (IMP) or a medical device (MD):
- INFARMED – Autoridade Nacional do Medicamento e Produtos de Saúde I.P. (National Authority of Medicines and Health Products);
- CEIC – Comissão de Ética para a Investigação Clínica (National Ethics Committee for Clinical Research);
- CNPD – Comissão Nacional de Protecção de Dados (Portuguese Data Protection Authority;
CETERA can also manage and support the full regulatory submission processes in other countries, mainly in the Portuguese-speaking countries where our full scientific advisory and translation services can be a key tool for a timely and efficient submission and approval process.
Our team will address all the concerns that may exist and help to find adequate solutions in the framework of the general and local regulation, assuring full compliance. CETERA will ensure that all the regulatory standards required are met, while establishing an efficient communication network between the Sponsor, CRO, Study Sites and Regulatory Authorities throughout all stages of the clinical study.
CETERA can give support in the following tasks:
- Clinical Trial Authorization Form;
- Translation and adaptation of study documents (e.g. Informed Consent Form, Product labelling, Patient card and further disclosure documents, etc);
- Study sites’ regulatory diligences;
- Complete submission to the Portuguese Authorities;
- Study submission at level site (Local Ethics Committee/Board of Directors);
- Substantial amendment preparation and submission;
- All regulatory notifications required;
- Pharmacovigilance – immediate and periodic safety notifications;
- Regulatory Advisory.
CETERA will definitely be a committed partner that will do all the efforts in order to implement your clinical studies. We compromise to provide fast and reliable answers to ensure regulatory compliance and contribute to the success of your project.
For further information or to get a quote this service, contact us.